The Latest Cardiac and Vascular News
FDA sets PDUFA date of December 30, 2020 BURLINGTON, Mass.–(BUSINESS WIRE)–scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that the U.S. Food and Drug Administration […]
BRISBANE, Calif., July 23, 2020 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to mavacamten, a novel, oral, allosteric modulator of cardiac myosin, for the treatment of symptomatic, obstructive hypertrophic cardiomyopathy (HCM). The FDA’s Breakthrough Therapy […]
Latest AI ultrasound tool makes it even easier to automatically assess ejection fraction, a key indicator of cardiac function, at the bedside–including on the front lines of the COVID-19 pandemic BRISBANE, Calif., July 23, 2020 /PRNewswire/ — Caption Health, a leader in medical AI technology, has received FDA 510(k) clearance for an […]
– Recently completed NODE-301 and ongoing NODE-301B studies can be used as two efficacy studies supporting a future NDA submission (target p-values of <0.05) – – NODE-301B, renamed the RAPID study, will reopen to enrollment and incorporate a repeat dosing regimen; results anticipated in late 2021/early 2022 – – Proceeds […]
Patient Selection to Begin Immediately for CoreoGraft Study IRVINE, CA / ACCESSWIRE / July 23, 2020 / Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI), a developer of medical devices that restore cardiac and vascular health, today announced that Italian Hospital Asuncion in Paraguay has given the Company permission to proceed with the CoreoGraft first-in-human study. […]
New stroke risk reduction technology designed to advance procedural performance and safety, treat wider range of patients with non-valvular atrial fibrillation MARLBOROUGH, Mass., July 21, 2020 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval for the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device. Experience […]
YOKNEAM, Israel, July 22, 2020 /PRNewswire/ — RealView Imaging Ltd. today announced the completion of its $10M series C financing round. New investors in this round include OurCrowd, a major hi-tech venture capital fund, Judith and Kobi Richter, among the most prominent technology and medical Israeli entrepreneurs, as well as other notable investors and leading physicians. The majority […]
Ongoing research with Northwestern Medicine to validate algorithms and help more accurately screen for heart murmurs and valvular heart disease during routine office visits OAKLAND, Calif.–(BUSINESS WIRE)–Eko today announced that it has been awarded a $2.7 million Small Business Innovation Research (SBIR) grant by the National Institutes of Health (NIH). The […]
LONG BEACH, Calif., July 21, 2020 /PRNewswire/ — Intuitive Surgical® has named MemorialCare Long Beach Medical Center as a Mentor Case Observation Site for robotic-assisted thoracic surgery using the da Vinci® Xi™ Surgical System. The designation of a case observation site means that at Long Beach Medical Center there is an expert surgeon, Amir Abolhoda, M.D., to […]
– Novel gene therapy designed to stimulate formation of new coronary blood vessels is being studied in patients with treatment-resistant angina with no remaining treatment options – July 21, 2020 07:00 AM Eastern Daylight Time MALVERN, Pa.–(BUSINESS WIRE)–XyloCor Therapeutics today announced it has successfully dosed the first two patients in […]
